Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04845763 |
| Other study ID # |
FQoR-15U |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
April 2021 |
| Source |
University Hospital, Angers |
| Contact |
Maxime Léger, MD |
| Phone |
2 41 35 36 35 |
| Email |
maxime.leger[@]chu-angers.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Recovery from surgery is a complex process, depending on the characteristics of the patient,
the anesthesia used, and the time required for surgical management.
In the context of emergency surgery, the perioperative period is associated with an increase
in morbidity and mortality, which may lead us to suspect an alteration in the quality of
recovery.
Different scales to measure the quality of post-operative recovery have been developed. The
QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These scoring tools
accurately measure postoperative recovery by addressing key domains: pain, physical comfort,
physical independence, psychological support and emotional state. Their use is recommended as
an endpoint for assessing patient comfort in clinical trials, according to the Standardized
Endpoints in Perioperative Medicine (StEP) initiative. In addition, monitoring of the QoR-15
is recommended by the American Society for Enhanced Recovery. A recent French translation of
the QoR-15 score has been validated for use in scheduled surgery.
All of these scores, regardless of the language in which they are translated, have been
developed and validated in patients who have undergone scheduled surgery. Until now, no
validated scoring tool has been available to assess recovery after emergency surgery, whether
traumatological or not.
Description:
Recovery from surgery is a complex process, depending on the characteristics of the patient,
the anesthesia used, and the time required for surgical management. This event is a source of
stress, anxiety, pain, and even complications, both minor (nausea, vomiting) and major (such
as surgical revision). The perioperative management and the psychological support allocated
to each patient will have an impact on the hospitalization experience.
In the context of emergency surgery, the perioperative period is associated with an increase
in morbidity and mortality, which may lead us to suspect an alteration in the quality of
recovery.
Most clinical studies are interested in the reduction of perioperative morbidity and
mortality (e.g. decrease in pain intensity measured by a visual analog scale, decrease in the
frequency of nausea/vomiting, decrease in the time to remobilization, etc.) but still few of
them evaluate in a global way the recovery, in particular in the emergency context.
Currently there is a desire to improve the physical and psychological recovery of our
patients. In this context, scales to measure the quality of post-operative recovery have been
developed. The QoR-40 and QoR-15 questionnaires assess recovery after elective surgery.These
scoring tools accurately measure postoperative recovery by addressing key domains: pain,
physical comfort, physical independence, psychological support and emotional state. Their use
is recommended as an endpoint for assessing patient comfort in clinical trials, according to
the Standardized Endpoints in Perioperative Medicine (StEP) initiative. In addition,
monitoring of the QoR-15 is recommended by the American Society for Enhanced Recovery. A
recent French translation of the QoR-15 score has been validated for use in scheduled
surgery.
All of these scores, regardless of the language in which they are translated, have been
developed and validated in patients who have undergone scheduled surgery. Until now, no
validated scoring tool has been available to assess recovery after emergency surgery, whether
traumatological or not.
